EVERY WOUND

IS PERSONAL3C Patch® – Clinical Trial Overview

02 EVERY WOUND IS PERSONAL

Reapplix 3C Patch®

Reapplix has established that one of the keys to

successful wound treatment lies in the body’s

capacity to heal – and each patient is central to

that process.

Reapplix's patented 3C Patch® is an innovative,

evidence-based biological wound treatment, made

entirely from the patient’s own blood – nothing else.

The efficacy and regenerative capability of 3C Patch®

is supported by solid clinical results, including a large

scale randomised controlled trial (RCT) published in

the highly recognised medical journal The Lancet

Diabetes & Endocrinology in 2018.

The RCT focused particularly on the

hardest-to-heal diabetic foot ulcers (DFU).

The results showed that 3C Patch® (in combination

with standard care) significantly enhances healing by nearly doubling the chance of wound healing

compared to standard care alone (adjusted odds

ratio of 1.89).

Based on the effectiveness demonstrated by these results, the 3C Patch® was included in the

IWGDF Guidelines 2019 as a recommended

adjunctive treatment for hard-to-heal DFUs.1

The 3C Patch® System comprises an automated

3CP® Centrifuge and a 3C Patch® Kit, which contains

single-use components: a blood sampling set,

a needle holder, a cover dressing and the

3C Patch® Device.

The 3C Patch® System is easy to use and requires

minimal hands-on time.

3C Patch® is applied directly to the wound, delivering

active cells and growth factors helping the patient

heal.

CLINICALLY PROVEN TO HELP PATIENTS HEAL THEIR CHRONIC WOUNDS

EVERY WOUND IS PERSONAL 03

AT REAPPLIX EVERY WOUND IS PERSONAL AND EVERY PATIENT COUNTS

04 EVERY WOUND IS PERSONAL

65%

1

90100

80

10

203040

50

60

70

2 3 4 5 6

TIME (WEEKS)

% IN

ITIA

L W

OU

ND

AR

EA

0

-0

r2=0.767 (P=0.0097)

Mean ±95% CI

• 15 patients included (16 wounds in total)

• Adult patients, with chronic cutaneous ulcers on the lower

extremities, chronic diabetic foot ulcers or amputation

wounds. DFU grade 1 or 2 according to the Wagner scale

• Most of the wounds included in the study had been present

for 2 years or more

PATIENTS2

The proportion of granulation tissue present in the wounds

increased significantly during the study from a mean of 32% at baseline to 72% at week six.

SIGNIFICANTLY INCREASED GRANULATION2

By six weeks wound area decreased by a mean of 65%.

SIGNIFICANT DECREASE IN WOUND AREA2

Prospective, uncontrolled, open-label study evaluating the

safety and clinical performance of 3C Patch® in chronic

wounds with different etiologies that had failed to heal using conventional, standard treatment approaches.

3C Patch® was prepared from blood donated by patients

at the point of care and applied to their wounds once a week

for six weeks, or until the wounds were completely healed.

STUDY DESIGN2

INTERVENTION2

Only two adverse events recorded, none of which was serious.

Neither was considered to be related to the 3C Patch®

treatment. No safety issues were identified.

KEY SAFETY DATA2

Pilot Study

EVERY WOUND IS PERSONAL 05

70%

80

100

60

40

20

3 8 13 18

TIME (WEEKS)

PER

CEN

TOFI

NIT

IAL

WO

UN

D A

REA

0-2

• 44 Adult patients, with at least one full-thickness diabetic

ulcer, classified by the investigator as Wagner grade 1 or 2 were included

• Duration of ulcers was longer than 6 weeks, and the ulcers

had a maximal area of 10 cm2

• Only "hard-to-heal" ulcers were included, i.e. ulcers that

did not reduce more than 40% in area over a 2 week

run-in period

• 5 patients did not complete the study resulting in Intention

To Treat (ITT) and Per Protocol (PP) populations of 44 and

39 respectively

PATIENTS3

Average wound area change in response to 3C Patch®

treatment (n=39). No average wound area change was

seen in the 2 week run-in period (week -2 to 0).

WOUND AREA CHANGE3

>70% of ulcers with duration between 8-25 weeks healed.

Prospective multicenter cohort study of patients with

hard-to-heal Wagner grade 1-2 diabetic foot ulcers.

HIGH HEALING RATE3

3C Patch® was applied once a week for up to 19 treatments, or

until the target ulcer was completely epithelised. In the

first treatment session, the ulcer was sharp-debrided before one or two patches were transferred to the ulcer, which was

then covered by a primary dressing. Secondary bandages were

applied as decided on a case by case basis and

changed depending on exudate levels.

STUDY DESIGN3

INTERVENTION3

No adverse events were judged to be related to the

patch treatment.

KEY SAFETY DATA3

Multicenter

Cohort Study

06 EVERY WOUND IS PERSONAL

70%

HEALED58%BONE

COVERED12%

• 22 patients included (26 ulcers in total)

• Non-ischemic (TcPO2≥ 30 mm Hg) DFUs with a duration of at least 6 weeks and a positive probing to bone test

were treated

• At least Wagner grade 3 hard-to-heal DFUs probing to bone

PATIENTS4

15 out of the total 26 DFUs healed with complete

epithelialisation.

HEALING WITH COMPLETE EPITHELIALISATION4

Bone was covered in 70% of the DFUs

(18 out of the total 26 DFUs).

COMPLETE BONE COVERAGE4

Open-label, case series evaluating the clinical performance of

the 3C Patch® treatment on hard-to-heal DFUs probing to bone.

3C Patch® was prepared during the patient’s visit at

the clinic. 18ml of the patient’s own venous blood were

drawn and processed for 20 minutes, without

anticoagulant or other additives.

The 3C Patch® (5cm2 area) was applied on the wound surface

once a week for up to 20 weeks, or until healing was completed.

STUDY DESIGN4

INTERVENTION4

No serious adverse events were recognized.

Tissue infection occurred in three cases but resolved

after change of oral antibiotic treatment.

KEY SAFETY DATA4

Probe-to-Bone

Case Series

EVERY WOUND IS PERSONAL 07

89%

58%

BEST STANDARD OF CARE

3C PATCH®

105 15 20 (WEEKS)

% (PATIENT HEALED)

RELATIVE INCREASE

40

30

20

10

0

• 269 were randomized between August 2013 and May 2017

• The groups were well matched at baseline and consisted

of those in most need of new treatment, those with

“hard-to-heal” DFUs

• “Hard-to-heal” defined rigorously as having DFUs that did not reduce in area more than 50% over a 4 week run-in

period despite best standard of care according to IGWDF

guidelines6 including debridement, offloading etc. as appropriate

PATIENTS5 58% more patients healed from the intervention

compared with best standard of care.5

COMPLETE WOUND CLOSURE5

89% more likely to heal.5

IMPROVED CHANCES OF HEALING5

3C Patch® was applied once a week for up to 20 treatments, or

until the target ulcer was completely epithelised. In the

first treatment session, the ulcer was sharp-debrided before one or two patches were transferred to the ulcer, which was

then covered by a primary dressing. Secondary bandages were

applied as decided on a case by case basis and

changed depending on exudate levels.

STUDY DESIGN5

INTERVENTION5

• No differences in adverse events or serious adverse events between groups.

• No device related serious adverse events.

• No differences in new anemia between groups, despite weekly blood sampling in the 3C Patch® group.

KEY SAFETY DATA5

International

multicenter RCT on

269 hard-to-heal

diabetic foot

ulcer patients

An independent multicenter, multinational, observer blinded,

investigator driven Randomized Controlled Trial on patients

with hard-to-heal Wagner grade 1-3 DFUs.

08 EVERY WOUND IS PERSONAL

Founded in 2008, Reapplix specializes in the biological treatment and

management of hard-to-heal wounds, especially diabetic foot ulcers. Its

innovative, patented 3C Patch® System draws on the individual patient’s

capacity to heal and is clinically proven to accelerate wound healing of

chronic diabetic foot ulcers and recommended by the IWGDF Guidelines

2019.1 Headquartered in Denmark, with sales and distribution teams in the

US and Europe, Reapplix won the Danish 2018 EY Entrepreneur of the Year

Award in the life science category.

(1) Rayman et al. Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update). Diab Metab Res Rev. 2020. e3283.

(2) Jørgensen, B., Karlsmark, T., Vogensen, H., Haase, L., & Lundquist, R. (2011). A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds. The International Journal of Lower Extremity Wounds, 10(4), 218–23

(3) Löndahl, M., Tarnow, L., Karlsmark, T., Lundquist, R., Nielsen, A. M., Michelsen, M., Jørgensen, B. (2015). Use of an autologous leucocyte and platelet rich fibrin patch on hard-to-heal DFUs: a pilot study. Journal of Wound Care, 24(4), 172–8.

(4) Fagher, K., Katzman, P., Asmundsson, Å., Ley, M. R., Larsson, G., Ahlberg, M. Löndahl, M. A leukocytes and platelet rich fibrin patch as a novel treatment of malleoli ulcers in patients with diabetes. POSTER ISDF. Den Haag, 2015.

(5) Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology. Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240

(6) Game FL, Attinger C, Hartemann A, Hinchliffe RJ, Löndahl M, Price PE, Jeffcoate WJ; International Working Group on the Diabetic Foot. IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:75-83.

OUR STORY

EUROPE (HQ)REAPPLIX A/S HQ / EUROPE

Blokken 45 · 3460 Birkerød Denmark

info@reapplix.com

VISIT US AT 3CPATCH.COM

USAREAPPLIX INC / US

325 Miron Drive, Suite 140

Southlake · Texas 76092· USA

info@reapplix.com

3C Patch® is formerly known as LeucoPatch. 3C Patch is a trademark of Reapplix A/S, registered in the EU and the US.

3CP is a trademark of Reapplix A/S, registered in the EU and pending in the US. 01979 EU & US Ver.1.0

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